Boston Scientific agrees to faulty-device payout

Thursday

Aug 30, 2007 at 12:01 AMAug 30, 2007 at 1:56 AM

Illinois will receive $605,000 from a $16.7 million payout by Boston Scientific Corp. that settles allegations of potentially life-threatening defects in implanted devices designed to jump-start failing hearts.

Dean Olsen

Illinois will receive $605,000 from a $16.7 million payout by Boston Scientific Corp. that settles allegations of potentially life-threatening defects in implanted devices designed to jump-start failing hearts.

As part of the settlement, Illinois Attorney General Lisa Madigan said Boston Scientific subsidiary Guidant Corp. has agreed to put in place safety programs and do first-ever public reporting of problems in the devices Guidant manufacturers.

The settlement would resolve a lawsuit Madigan filed Thursday in Sangamon County Circuit Court. She has asked Circuit Judge Patrick Londrigan to approve a proposed consent decree.

Madigan and attorneys general from 34 other states and the District of Columbia alleged that Guidant waited until 2005 to tell doctors and the public that it had sold defective implanted defibrillators in 2002 and 2003, even though the company knew the products had problems.

About 150 Illinois residents were among those who received a total of 4,000 Guidant defibrillators with an alleged defect that could prevent the devices from working properly, according to lawyers from Madigan’s office.

It’s unknown whether the defect caused any of those 150 people to suffer medical complications or death, the lawyers said.

Guidant admitted no liability in the settlement, which expands a warranty program for patients who may not have already sought free replacement defibrillators. All patients with the potentially defective devices were notified in 2005.

The $605,000 for Illinois will reimburse the attorney general’s office for costs associated with the investigation, said Debbie Hagan, chief of Madigan’s consumer-protection division.

But Hagan said the settlement is most important because it establishes public reporting of defects and other safety measures — including an independent patient-safety advisory board — affecting one of the world’s largest makers of implanted defibrillators.

“This is what we think is going to move the market along,” she said. “We have brought physicians and the public into watching this process.”

The settlement is separate from a tentative $195 million settlement that Boston Scientific agreed to pay last month to resolve 4,000 claims in a Minnesota-based federal class-action lawsuit involving faulty Guidant heart devices.

Hagan said she didn’t know whether any of those 4,000 claims involved Illinois patients.

Boston Scientific also faces other pending lawsuits in the United States and overseas over its heart products.